APEX CR Knee KC-1445RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841690104308), received between Sep 6, 2019 and Mar 13, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY DATE IS (B)(6) 2022. THE REASON FOR REVISION IS REPORTED TIGHT JOINT. DURING THE REVISION, THE KNEE WAS MANUALLY MANIPULATED UNDER ANESTHESIA TO HELP RELIEVE THE STIFFNESS IN THE JOINT.

  Patient problems: Joint Contracture

  MAUDE report 16527333 ↗
• InjuryJul 10, 2020Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS (B)(6) 2019. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, THEY REMOVED THE ORIGINAL FEMORAL COMPONENT, BASEPLATE, TIBIAL INSERT, LOCKING BOLT AND PATELLA AND REPLACED THEM WITH NEW COMPONENTS. THEY ALSO ADDED TWO FLUTED STEMS DURING THE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 10258903 ↗
• InjurySep 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6). THE ORIGINAL SURGERY DATE IS (B)(6) 2018. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE TIBIAL INSERT, FEMORAL COMPONENT, AND RETAINING BOLT WERE ALL REVISED TO NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 8972437 ↗